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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; UNO INSET II 46/6 SC1 PINK MCAN
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MIO¿; UNO INSET II 46/6 SC1 PINK MCAN Back to Search Results
Model Number MMT-921A600
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2021, it was reported that the patient's infusion set's tubing came apart.No further information available.
 
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Brand Name
MIO¿
Common Device Name
UNO INSET II 46/6 SC1 PINK MCAN
MDR Report Key12517765
Report Number3003442380-2021-00489
Device Sequence Number3990648
Product Code FPA
UDI-Device Identifier05705244020214
UDI-Public05705244020214
Combination Product (Y/N)Y
PMA/510(K) Number
K160648
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Expiration Date01/01/2023
Device Model NumberMMT-921A600
Device Lot Number5309814
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/10/2021
Initial Report FDA Received Date09/23/2021
Usage of Device N
Patient Sequence Number1
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